Standard and reduced dose NOACs showed similar stroke risks in AF patients, but standard-dose rivaroxaban had a higher major bleeding risk (2.78%) compared to dabigatran (ARD -0.93%).
Cohort (n=31,522)
Yes
Does the choice of NOAC (dabigatran, rivaroxaban, apixaban) at standard or reduced doses affect the risk of stroke/thromboembolism and bleeding in oral anticoagulant-naïve patients with atrial fibrillation?
In a nationwide cohort of AF patients, standard and reduced doses of dabigatran, rivaroxaban, and apixaban showed similar effectiveness for stroke prevention, but rivaroxaban was associated with higher major bleeding risk.
Absolute Risk Reduction: -0.93 (95% CI -1.45–-0.38)
Absolute Risk Reduction: -0.93%
BACKGROUND: Comparative data of non-vitamin K antagonist oral anticoagulants (NOAC) are lacking in patients with atrial fibrillation (AF). OBJECTIVE: We compared effectiveness and safety of standard and reduced dose NOAC in AF patients. METHODS: Using Danish nationwide registries, we included all oral anticoagulant-naïve AF patients who initiated NOAC treatment (2012-2016). Outcome-specific and mortality-specific multiple Cox regressions were combined to compute average treatment effects as 1-year standardized differences in stroke and bleeding risks (g-formula). RESULTS: Amongst 31 522 AF patients, the distribution of NOAC/dose was as follows: dabigatran standard dose (22.4%), dabigatran-reduced dose (14.0%), rivaroxaban standard dose (21.8%), rivaroxaban reduced dose (6.7%), apixaban standard dose (22.9%), and apixaban reduced dose (12.2%). The 1-year standardized absolute risks of stroke/thromboembolism were 1.73-1.98% and 2.51-2.78% with standard and reduced NOAC dose, respectively, without statistically significant differences between NOACs for given dose level. Comparing standard doses, the 1-year standardized absolute risk (95% CI) for major bleeding was for rivaroxaban 2.78% (2.42-3.17%); corresponding absolute risk differences (95% CI) were for dabigatran -0.93% (-1.45% to -0.38%) and apixaban, -0.54% (-0.99% to -0.05%). The results for major bleeding were similar for reduced NOAC dose. The 1-year standardized absolute risk (95% CI) for intracranial bleeding was for standard dose dabigatran 0.19% (0.22-0.50%); corresponding absolute risk differences (95% CI) were for rivaroxaban 0.23% (0.06-0.41%) and apixaban, 0.18% (0.01-0.34%). CONCLUSIONS: Standard and reduced dose NOACs, respectively, showed no significant risk difference for associated stroke/thromboembolism. Rivaroxaban was associated with higher bleeding risk compared with dabigatran and apixaban and dabigatran was associated with lower intracranial bleeding risk compared with rivaroxaban and apixaban.
Stærk et al. (Fri,) conducted a cohort in Atrial fibrillation (n=31,522). Non-vitamin K antagonist oral anticoagulants (dabigatran, rivaroxaban, apixaban) vs. Active comparators (head-to-head NOAC comparisons) was evaluated on Major bleeding (dabigatran vs rivaroxaban standard dose) (Absolute risk difference -0.93%, 95% CI -1.45 to -0.38). Standard and reduced dose NOACs showed similar stroke risks in AF patients, but standard-dose rivaroxaban had a higher major bleeding risk (2.78%) compared to dabigatran (ARD -0.93%).
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